2010-19530. Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) and National Institutes of Health (NIH), with support from the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and Interventions (SCAI) are announcing a public workshop entitled “Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices.” The topic to be discussed is pediatric cardiovascular device development. The purpose of the public workshop is to solicit information from clinicians, academia, professional societies, other government agencies, and industry on various efficient and pragmatic clinical trial designs that are conducive to overcoming the challenges in developing devices for the pediatric cardiology market. The information gathered in this and future workshops will help to develop future guidance on optimal designs for pediatric cardiology device trials.

Date and Time: The public workshop will be held on September 30, 2010, from 8 a.m. to 5:30 p.m.

Location: The public workshop will be held at Moscone Center, 747 Howard St., San Francisco, CA 94103.

Contact Person: Francesca Joseph, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5277, Silver Spring, MD 20903, 301-796-6805, FAX: [phone], e-mail: [e-mail].

Registration: Registration information will be posted on the Internet at http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​default.htm.

If you need special accommodations due to a disability, please contact Lynn Colegrove by phone [phone] at least 7 days in advance.

Registration and seating will be on a first-come, first-served basis. A discussion preference will be afforded to clinical research investigators involved in pediatric clinical device trials, health care givers, and patient advocates. There is no registration fee to attend the public workshop. Early registration is recommended because seating is limited. There will be no onsite registration.

Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

SUPPLEMENTARY INFORMATION:

In the medical device industry, rarely have devices been developed, evaluated, and approved specifically for treatment of children with congenital heart disease. The small, heterogeneous population, need for long-term followup, lack of market incentive, and misperceptions of regulatory requirements and costs are a few of the issues that make a standard randomized control trial difficult to conduct in pediatric cardiology. The goal of the workshop is to educate the medical device industry and pediatric clinical community about device development and regulatory approval processes, and to identify clinical trial designs that lend themselves to overcoming the challenges in pediatric cardiovascular device development. Subsequently making this information available to industry, the clinical community, and the public is imperative to furthering the development of pediatric cardiovascular devices and alleviating this critical unmet need. The marketing approval of more cardiovascular devices specifically designed and/or labeled for pediatric patients would have a significant impact on public health. Invited experts will address types of clinical trials with a particular focus on trial designs and statistical analysis methods, as well as alternative sources of clinical data, that can help to address the challenges in this particular patient population. After each section there will be an audience question and answer session and panel discussion allowing workshop participants to interact with the speakers and panelists. A concluding session will allow for additional interactions.

Background information on the public workshop, registration information, the agenda, information about lodging, and other relevant information will be posted, as it becomes available, on the Internet at http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​default.htm.

Dated: August 4, 2010.

Nancy Stade,

Acting Associate Director for Regulations and Policy, Center for Devices and Radiological Health.